FDA product code FCP: Box, Battery, Pocket
FCP is the FDA product code for box, battery, pocket. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FCP, from 2 different applicants. The average 510(k) review took 238 days (median 238). FDA has posted 1 recall for FCP devices.
Classification
| Field | Value |
|---|---|
| Device name | Box, Battery, Pocket |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCP clearance
Top FCP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lucas & Rhea Mfg. | 1 | 1990-04-26 |
| Dowit Service Co., Inc. | 1 | 1988-07-26 |
Most recent FCP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891927 | Lucas & Rhea Mfg. | TELEMETRY POWER PACK MODEL 2 | 1990-04-26 | 394 |
| K881885 | Dowit Service Co., Inc. | BATTERY PACKS (OTHER THAN CV) | 1988-07-26 | 83 |
Recalls for FCP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-11.
Frequently asked questions
What is FDA product code FCP?
FCP is the FDA product code for box, battery, pocket. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FCP?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCP?
Across 2 cleared submissions the average was 238 days from receipt to decision (median 238).
Which companies have the most FCP clearances?
Lucas & Rhea Mfg. (1); Dowit Service Co., Inc. (1).
Have FCP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code FCP
- Run a recall and safety report across every FCP manufacturer
- Watch product code FCP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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